Thanks to the generous
Sponsors and Exhibitors of the
2010 FDLI Annual Conference
2010 FDLI Annual Conference Sponsors & Exhibitors

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CLE
Pending state approvals, Continuing Legal Education credits
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Featured Speakers

Featured Speakers for the 2010 FDLI Annual Conference will be posted as they are confirmed.


Agenda

New location this year!
The 2010 FDLI Annual Conference will be held at:
Hilton Washington Hotel
1919 Connecticut Avenue, NW
Washington, DC 20009

This Conference is developed for intermediate to seasoned professionals in law, regulatory, policy, compliance, marketing/public relations and management working in or representing FDA-regulated companies.

View the agenda for Friday, April 23

View the Leadership Meetings Schedule


Thursday, April 22
All events are scheduled to be held on the Concourse Level
(Schedule may change)

7:00 a.m.
Registration and Continental Breakfast (Concourse Foyer)

7:00 a.m.–7:00 p.m.
FDLI Resource Center and Exhibits Open (Concourse Foyer)

8:15–10:00 a.m.
FDLI Welcome (International Ballroom East)
Susan C. Winckler, RPh, JD, President and CEO, FDLI
Fred H. Degnan, Partner, King & Spalding LLP and FDLI Board Chair

I. Major Addresses - Plenary (International Ballroom East)
Moderated by Fred Degnan

A. Margaret A. Hamburg, MD, Commissioner, Food and Drug
Administration (FDA)

B. Ralph S. Tyler, Chief Counsel, FDA

C. Michael A. Chappell, Associate Commissioner for Regulatory Affairs (Acting) and Deputy Associate Commissioner for Field Operations, Office of Regulatory Affairs, FDA

10:00-10:30 a.m.
Refreshment Break (Concourse Foyer)

10:30 a.m.–12:30 p.m.
II. Major Addresses - Plenary (continued in International Ballroom East)

The Food and Drug Administration Alumni Association’s
Harvey W. Wiley Lecture Award
The 2010 Wiley Award Winner is Richard A. Merrill, Daniel Caplin Professor of Law Emeritus at the University of Virginia School of Law and Retired Senior Of Counsel, Covington & Burling LLP

Enforcement Roundtable

Moderator
Mary K. Pendergast, JD, LLM, President,
Pendergast Consulting

Panelists
Eric M. Blumberg, Deputy Chief for Litigation, Office of the Chief Counsel, FDA
Mark S. Brown, Partner, King & Spalding LLP
Richard M. Cooper, Partner, Williams & Connolly LLP
Lewis A. Grossman, PhD, JD, Professor of Law, Associate Dean for Scholarship, American University

12:30-2:00 p.m.
Lunch (International Ballroom Center)

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2:00-3:30 p.m.
III. Center Directors/Deputy Directors -
States of the Centers and 2010 Priorities
(Concourse Level Meeting Rooms)

A. Biologics (Jefferson East)
Diane M. Maloney, JD, Associate Director for Policy, Center for Biologics Evaluation and Research (CBER), FDA

Moderator
Areta L. Kupchyk, Partner, Reed Smith LLP

Panelists
Glenn N. Byrd, MBA, RAC, Director, Regulatory Affairs, Advertising and Promotion, MedImmune, Inc.
Sara Radcliffe, Vice President, Science and Regulatory, Biotechnology Industry Organization

B. Drugs (International Ballroom East)
Janet Woodcock, MD, Director, Center for Drug Evaluation
and Research (CDER), FDA

Moderator
Daniel A. Kracov, Partner, Chair, FDA and Healthcare Practice Arnold & Porter LLP

Panelists
Andrew C. Fish, Senior Vice President and General Counsel, Consumer Healthcare Products Association
Jeffrey K. Francer, Assistant General Counsel, PhRMA
Roy J. Sturgeon, PhD, President, Lachman Consultant Services Inc.
Generic Pharmaceutical Association (invited)

C. Medical Devices, Radiological Health, Diagnostics
(Lincoln West)
Jeffrey E. Shuren, MD, JD, Director, Center for Devices
and Radiological Health (CDRH), FDA

Moderator
Jennifer L. Bragg, Partner, Skadden, Arps, Slate,
Meagher & Flom

Panelists
David E. Chadwick, PhD, RAC, Regulatory Scientist, Regulatory Affairs Cook, Inc.
E. Stewart Crumpler, Principal Consultant,
Quintiles Consulting
Marc J. Scheineson, Partner, Alston & Bird LLP

D. Foods, Dietary Supplements, Cosmetics (Jefferson West)
Stephen F. Sundlof, DVM, PhD, Director, Center for Food Safety and Applied Nutrition (CFSAN), FDA, and, USDA Representative

Moderator
Rachel G. Lattimore, Partner, Arent Fox LLP
                                   
Panelists
Benjamin L. England, President/CEO, FDAImports.com, LLC
Daniel F. Shaw, Vice President and Deputy General Counsel, H.J. Heinz Company
Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest

E. Veterinary Medicine, Animal Health (Monroe)
Tracey H. Forfa, JD, Executive Director, Center for Veterinary Medicine (CVM), FDA

Moderator
Theodore M. Sullivan, Attorney, Buchanan Ingersoll
& Rooney PC

Panelists
Stephanie Batliner, Chair, Generic Animal Drug Alliance
M. Elizabeth McKenzie, PhD, Director, U.S. Regulatory Affairs Veterinary Medicine Research and Development, Pfizer Animal Health
Michael T. Van Koevering, PhD, Director, Regulatory Surveillance and Compliance, Elanco Animal Health

F.Tobacco Products (Lincoln East)
Lawrence R. Deyton, MSPH, MD, Director, Center for Tobacco Products (CTP), FDA

Moderator
William B. Schultz, Partner, Zuckerman Spaeder LLP and FDLI Immediate Past Board Chair

Panelists
Nancy L. Buc, Partner, Buc & Beardsley, LLP
Matthew L. Myers, Esq, President, Campaign for Tobacco-Free Kids
Jeremy Sharp, Professional Staff Member, Subcommittee on Children and Families, HELP Committee, U.S. Senate

3:30-4:00 p.m.
Refreshment Break (Concourse Foyer)

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4:00-5:30 p.m.
IV. Concurrent Breakout Sessions
(Concourse Level Meeting Rooms)

A. Major Issues and Breaking News in Drug and Device
Law During 2009 (Jefferson East)
A discussion of twenty court cases that are moving the law affecting food and drug manufacturers in new, or potentially new, directions, will take place. It will include an analysis of filed cases that could result in significant changes in the role of FDA and its enforcement activities, a review of settlements that significantly affect the activities of manufacturers subject to food and drug law and regulation, and an examination of the changing administrative scope and performance of the FDA.

Following this breakout session, please attend the Networking Reception and the Meet-and-Greet with authors of Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010 in the Concourse Foyer.

Moderator
John B. Reiss, PhD, Partner, Saul Ewing LLP

Speakers
Michael H. Hinckle, Partner, K&L Gates LLP
William M. Janssen, Assistant Professor of Law,
Charleston Law School
Michael A. Swit, Vice President,
The Weinberg Group Inc.

B. Personalized Medicine: Co-development of Therapeutics
and In Vitro Diagnostics (International Ballroom East)
Personalized medicine holds the promise of targeted therapeutics - the tailoring of treatment based on an individual’s genetic profile. FDA has struggled for years with how to approach co-development of therapeutics and diagnostics, due to both organizational and scientific issues; at the same time, several leading biopharma companies are moving in the direction of co-development. The purpose of this panel is to foster a dialogue among key stakeholders, including industry, government and academia, on potential approaches to the main issues surrounding co-development. Be sure to attend the Networking Reception following this session, and the Meet and Greet with authors of FDLI’s new publication, In Vitro Diagnostics: The Complete Regulatory Guide. Both events are in the Concourse Foyer.

Moderator
Nancy B. Myers, JD, President, Catalyst Healthcare Consulting, Inc.

Speakers
Edward Abrahams, PhD, Executive Director, Personalized Medicine Coalition
Kathy L. Hudson, PhD, Chief of Staff, Office of the Director, National Institutes of Health
William J. Pignato, Global Head, Regulatory Affairs, Novartis Molecular Diagnostics
Vicki L. Seyfert-Margolis, PhD, Advisor to FDA’s Chief Scientist, OC, FDA

C. Case Studies in Combination Product Regulation
and Product Classification (Lincoln West)
This session will explore the recent developments in combination product regulation – including the proposed rules on combination product Good Manufacturing Practices and post-market safety reporting – using a dynamic and interactive case study approach.  Guided by agency and industry moderators, session participants will analyze real-life scenarios involving complex combination product regulatory issues.

Moderator
Bradley Merrill Thompson, Epstein Becker
& Green, P.C.

Speakers
Suzanne L. Kiani, Senior Scientist, Pharma Technical Regulatory, Genentech, Inc.
Lee H. Leichter, President, P/L Biomedical
John B. Weiner, Associate Director for Policy & Product Classification Officer, Office of Combination Products, OC, FDA

D. How Regulatory Structures are taking into Account Scientific Developments in Assessing Approved Food Contact Products (Jefferson West)
This session will present the current legal and regulatory status in the EU and the US and how the regulatory structures are dealing with scientific developments previously-approved food contact products. Other discussion items include:
· ongoing and recent studies
· testing approaches and controversies over validity
· relevance of scientific and toxicological findings for public health

Moderator
Stephen Paul Mahinka, Partner, Chair,
Life Sciences Interdisciplinary Practice, Morgan,
Lewis & Bockius, LLP

Speakers
Jerrold J. Heindel, PhD, Health Science Administrator, National Institute of Environmental Health Sciences, National Institutes of Health
Jane Muncke, PhD, Environmental Risk Assessment Specialist, Emhart Glass SA
Frederick S. vom Saal, PhD, Curators' Professor of Biology, Division of Biological Sciences, College of Arts & Sciences, University of Missouri - Columbia

Speakers (invited)

E. Animal Drug Compounding (Monroe)
Animal drug compounding has long been an important means by which veterinarians effectively treat their patients, yet significant controversy and confusion persists among veterinarians, compounding pharmacists, regulators and the legal community as to the appropriate manufacture and use of compounded products.  This session will explore the complex legal and regulatory status regarding the practice of animal drug compounding, the implications of higher profile adverse events related to the use of compounded drugs and the effect on the actual practice of veterinary medicine.

Moderator
Sheila D. Walcoff, Partner, McDermott, Will & Emery

Speakers
Sheldon T. Bradshaw, Partner and Co-Chairman, Food and Drug Practice, Hunton & Williams LLP
Jayne T. Tung, DVM, Independent Equine Practitioner and Small Animal Emergency Clinician, Frederick Emergency Animal Hospital

F. Tobacco: Harm Reduction Strategies (Lincoln East)
This session will examine approaches to harm reduction from tobacco products and the challenges in developing a responsible regulatory path forward. Discussion will include Modified Risk Tobacco Products (MRTP) under section 911 of the Federal Food, Drug, and Cosmetic Act (FDCA) and the role that labeling, as well as controls over promotion and advertising, may play in advancing public health. Attend this session to listen to the perspectives from some of the key opinion leaders.

Moderator
Philip J. Phillips, President, Phillips Consulting
Group, LLC

Speakers
Anthony P. Albino, PhD, Vice President for Public Health A‚ airs for Vector Group Ltd., Senior Vice President for Public Health A‚ airs at Vector Tobacco Inc, and President and CEO of Vector Research LLC
Scott D. Ballin, Tobacco and Health Policy Consultant
Jed E. Rose, PhD, Director, Center for Nicotine and Smoking Cessation Research, and, Professor, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center
James E. Swauger, PhD, DABT, Vice President, RAI Services, Inc.

5:30-7:00 p.m.
Networking Reception (Concourse Foyer)

Meet-and-Greet with Authors of Top 20 Food and Drug Cases, 2009 & Cases to Watch, 2010 and In Vitro Diagnostics: The Complete Regulatory Guide, plus Book Raffle Drawing (Concourse Foyer)

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View the agenda for Friday, April 23

View the Leadership Meetings Schedule